Quality Control Head (API division), Mahad with a leading API Mfg Co

Established in the year 1986, our client co. is the world's second largest Integrated manufacturer of Ephedrine and Pseudoephedrine salts. Our client's manufacturing facility at Mahad has been audited and approved by the Australian TGA, and the US FDA

Post: Head QC

Job Description:
• Effectively supervising a team and technical associates for Quality Control, Co-ordination of analytical method validation activity to fulfill regulatory and guidelines requirements.
• New SOP, STP and protocol preparation and implementation as per GLP norms.
• Preparation of qualification (IQ, OQ and PQ) report for new instruments.
• Review the documents received from R&D,Review the existing STPs, SOPs and update them if required
• Help the team members manage change controls, deviations, incidents
• Support audits/ quality investigations issues
• Coordinating with internal as well as QA providing support to Regulatory Affairs
• Exposure to preparation and execution of forced degradation and stability studies protocols
• Exposure to handling of OOS and OOT results
• Exposure to training of QC personnel for on-the-job training.
• Exposure to development and validation of analytical methods for organic volatile impurities by Head-space GC
• Exposure to maintenance and troubleshooting of analytical instruments
• Exposure to independent handling of regulatory and customer audits

Candidate Profile
MSc Chemistry Candidates Only.
Experience in handling complete QC activities in API Mfg Co. is a must.
Current Designation should be either Asst. Manager QC or QC Manager or above
Ready to relocate to Mahad

Additional Information:
Location: Mahad (Raigad Dist.), Maharashtra
Education: M.Sc Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QC
End Date: 8^th November, 2014